Status:
COMPLETED
A Study to Assess Safety and Efficacy of a Novel Patch Infusor Device and Novel SUBCUTaneous Furosemide Formulation Combination in Patients With Heart Failure
Lead Sponsor:
SQ Innovation, Inc.
Collaborating Sponsors:
University of Glasgow
NHS Greater Glasgow and Clyde
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a single-centre, prospective, open-label, non-comparative clinical trial assessing the on-body performance of an investigational drug delivery device (SQIN-Infusor) in patients hospitalised du...
Detailed Description
The investigational product consists of a novel higher concentration (30mg/mL) furosemide formulation developed for subcutaneous administration and a novel patch pump placed on the abdominal skin. Thi...
Eligibility Criteria
Inclusion
- • Written informed consent
- Male or female ≥18 years of age
- Meet ESC criteria for diagnosis of HF(4)
- Inpatient with a primary diagnosis of HF requiring treatment with intravenous furosemide at dose
Exclusion
- • Unable to consent to inclusion in study due to lack of capacity
- Requiring treatment with intravenous furosemide at dose \>200 mg per day as determined by the usual care team
- Current inotropes, vasopressors or intra-aortic balloon pump therapy
- Concomitant use of diuretics in 12 hours preceding administration of study drug with SQIN-Infusor
- Systolic blood pressure (SBP) \<90 mmHg
- Pregnancy or breastfeeding
- Left sided valve disease with planned surgery or percutaneous intervention
- Type 1 myocardial infarction during index hospitalisation (type 2 myocardial infarctions are allowed)(5)
- Any surgical or medical condition which prevents patient from ambulation during the infusion
- Renal impairment, defined as eGFR \< 30 mL/min/1.73 m2 at screening.
- Patient on active cardiac transplant waiting list
- Potassium \<3.0 mmol/L
- Potassium \>6.0 mmol/L
- Sodium \<125 mmol/L
- Any contraindications for furosemide administration as per furosemide SmPC
- Any surgical or medical conditions, which in the opinion of the investigator may pose an undue risk to the subject, interfere with participation in the study or which may affect the integrity of the data
Key Trial Info
Start Date :
May 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 13 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04846816
Start Date
May 6 2021
End Date
August 13 2021
Last Update
November 26 2021
Active Locations (1)
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1
Queen Elizabeth University Hospital, NHS Greater Glasgow & Clyde
Glasgow, United Kingdom, G51 4TF